Global CMC Regulatory Director for Cell & Gene Therapies

US Diversity Job Search; Gaithersburg (MD); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health, Vision, and Dental insurance

401(k) plan

Bonus opportunities

Job summary

Miltenyi Biomedicine Inc. seeks a senior regulatory leader for CMC/CGT to guide global strategies across development, registration and lifecycle management. You will drive regulatory leadership, collaborate across functions, and oversee submissions to major health authorities worldwide.

Applicants should have 12+ years in CMC regulatory affairs for CGT products, with strong leadership, communication and strategic skills in a globally integrated team.

Qualifications

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline.
• Extensive experience in Regulatory Affairs within biotechnology/pharmaceuticals.
• Substantial experience with global regulatory submissions & health authority interactions.
• Deep understanding of biologics, ATMPs, CGT products and global regulatory frameworks.
• Excellent communication, leadership and project management skills.
• Fluent English written and verbal communication.
• Experience in regulatory strategy and submissions for Cell therapies, Gene therapies, viral vectors, ATMPs.

Responsibilities

• Lead global CMC regulatory strategies for CGT products across development and commercialization.
• Oversee CMC sections for regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, post-approval variations).
• Provide guidance on regulatory requirements for manufacturing processes, analytics, specs, comparability, process validation and control strategies.
• Assess regulatory impact of manufacturing changes and define worldwide pathways.
• Support interactions with FDA, EMA, MHRA and other authorities.
• Collaborate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development.
• Monitor regulatory trends and translate into strategies; drive risk assessments and mitigation across lifecycle.

Skills

Regulatory leadership

Communication skills

Project management

Leadership

English proficiency

Education

Master's or PhD in related field

Job description

Miltenyi Biomedicine Inc. seeks a senior regulatory leader for CMC/CGT to guide global strategies across development, registration and lifecycle management. You will drive regulatory leadership, collaborate across functions, and oversee submissions to major health authorities worldwide.

Applicants should have 12+ years in CMC regulatory affairs for CGT products, with strong leadership, communication and strategic skills in a globally integrated team.